Ireland· IE-PA-EU/1/21/1564/001
IMCIVREE 10 mg/ml solution for injection
A centrally acting antiobesity products product containing setmelanotide, registered in Ireland by Rhythm Pharmaceuticals Netherlands B.V.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Setmelanotide
- Manufacturer
- Rhythm Pharmaceuticals Netherlands B.V
- Country
- Ireland (IE)
- ATC code
- A08AA
- ATC class
- Centrally acting antiobesity products
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/21/1564/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Setmelanotide in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FranceIMCIVREE 10 mg/ml, solution injectableRHYTHM PHARMACEUTICALS NETHERLANDS (PAYS-BAS)
- NetherlandsImcivree 10 mg/ml oplossing voor injectieRhythm Pharmaceuticals Netherlands B.V.
- CzechiaIMCIVREERhythm Pharmaceuticals Netherlands B.V., Amsterdam
- IcelandIMCIVREERhythm Pharmaceuticals Netherlands B.V
- SwitzerlandIMCIVREE 10 mg/ml, InjektionslösungRhythm Pharmaceuticals Switzerland GmbH
- SpainIMCIVREE 10 MG/ML SOLUCION INYECTABLERhythm Pharmaceuticals Netherlands B.V.
- FinlandImcivreeRhythm Pharmaceuticals Netherlands B.V.
- United KingdomImcivree 10mg/1ml solution for injection vialsRhythm Pharmaceuticals UK Ltd
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Imcivree
- Liechtenstein · Imcivree
- Norway · Imcivree
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of HPRA (Ireland). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/ecb07bed-ea8d-43bf-9ade-659d6869f6dd GET /v1/drugs/ecb07bed-ea8d-43bf-9ade-659d6869f6dd?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"form": "Solution for injection",
"routes": [
"Subcutaneous use"
],
"source": "hpra",
"atc_all": [
"A08AA"
],
"strength": null,
"pa_number": "EU/1/21/1564/001",
"substances": [
"Setmelanotide"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "16/07/2021",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about setmelanotide.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.